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**Update on Rifamycin Issues**
September 14, 2020
Dear Colleague:
On August 26, 2020, FDA issued a statementexternal icon related to mitigating shortages of rifampin and rifapentine and its interim guidance to continue using these drugs in the treatment of tuberculosis (TB) after nitrosamine-class impurities were detected through recently adopted regulatory standards to assay all medications for nitrosamines.  FDA sets standard limits on the concentrations of the impurities and is allowing distribution of rifampin and rifapentine if the concentrations do not exceed interim limits while the impurities are investigated. This letter updates CDC’s Division of TB Elimination (DTBE) Dear Colleague Letters of June 19 and August 19, 2020. CDC’s DTBE recommends that providers continue prescribing rifampin and rifapentine for all TB and latent TB infection (LTBI) treatment per existing guidelines.
**Background**
FDA only recently began including testing for nitrosamines, which are potential carcinogens, in rifampin and rifapentine as part of its drug safety requirements. It is possible that nitrosamines were present in rifampin and rifapentine for a substantial time (years or decades) prior to introduction of these tests. DTBE is not aware of any data showing an association between cancer and use of rifamycins in humans. However, DTBE is also not aware of any rigorous studies that have looked for this association.
**Information on Rifampin**
Unrelated to the detection of nitrosamine impurities, Sanofi announced the discontinuation of three oral rifampin-containing products: Rifadin® (rifampin 150 mg and 300 mg capsules); Rifamate® (a fixed-drug combination of isoniazid and rifampin), and Rifater® (a fixed-drug combination of isoniazid, rifampin, and pyrazinamide) in June 2020.  Information on drug shortages and discontinuations is available from FDAexternal icon.  FDA is working with other manufacturers to maintain availability of rifampin, and there is no national shortage of rifampin at present. Rifampin should be prescribed as an essential part of a multi-drug regimen for the treatment of active TB diseaseexternal icon. Rifampin can also be prescribed, as 3 months of daily isoniazid and rifampin (3HR) or 4 months of daily rifampin (4R), for treating LTBI to prevent the development of active TB disease per current National TB Controllers Association (NTCA)/CDC guidelines.
**Information on Rifapentine**
In June 2020, shipments of rifapentine (supplied as Priftin® 150 mg film-coated tablets manufactured by Sanofi) were paused after a nitrosamine impurity was found. FDA and Sanofi have not announced when shipments will resume, and FDAexternal icon still lists rifapentine as “Currently in Shortage.” Where local supplies of rifapentine are enough for complete regimens, providers can continue to prescribe the 3-month regimen of weekly rifapentine with isoniazid (3HP) for treating LTBI. Where rifapentineexternal icon is in shortage, providers can consider other rifamycin-based regimens such as 3HR or 4R, which have completion rates comparable to 3HP.
**Information on Drug Treatment Continuation for LTBI**
Patients who are already taking rifampin or rifapentine-containing regimens for LTBI can continue their treatment. If a clinician or a patient prefers to discontinue one of these regimens, a complete regimen of 6 or 9 months of isoniazid can be started, or the original regimen can be completed with a proportionate duration of one of the isoniazid-only regimens. However, isoniazid regimens are associated with increased risk of drug-induced liver injury and lower completion rates. Therefore, CDC does not recommend discontinuing rifamycin-based short-course LTBI treatment in favor of isoniazid-only treatment unless necessitated by another event (e.g., adverse reaction to a rifamycin).
**Reporting Rifamycin Supply Issues**
Information of drug shortages and discontinuations are available from FDAexternal icon. DTBE recommends that you periodically assess your rifampin and rifapentine availability with your pharmacy or your suppliers. Please keep your CDC project officer for your jurisdiction’s TB cooperative agreement updated by e-mail message or telephone. If you find a shortage or if you are forecasting a shortage, please notify FDA directly by e-mail (drugshortages@fda.hhs.gov) or telephone (240-402-7770). You also can report a shortage to the National Tuberculosis Controllers Association (NTCA) with a form on its home page, http://www.tbcontrollers.org/external icon. Questions related to this letter should be sent to CDC by email (tbinfo@cdc.gov) or phone (770-488-7100).
CDC will continue to monitor the situation closely and work with our partners at FDAexternal icon, NTCAexternal icon, state and local health departments, and the TB Centers of Excellence for Training, Education, and Medical Consultation to ensure TB patients continue to receive safe and effective treatment.
Sincerely,
**Terry Chorba**
Terence Chorba, MD, DSc
Chief, Field Services Branch, Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention
1600 Clifton Road NE (US 12-4), Atlanta, GA 30329
							
					
						Page last reviewed:  September 14, 2020					Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force To receive email updates about this page, enter your email address: Email Address			What's this?				Submit


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